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Fukuda Denshi Op-114te
EUDAMEDClass I (EU MDR)
Ref ACC-FD63100/300RSModel Accu-PlusRef SK-FD-63100-300RSModel SKYMEDRef SK-FD63100-300RS
Identity
- Trade Name
- FUKUDA DENSHI OP-114TE EUDAMED
- Device Name
- Medical Chart Recording Paper EUDAMED
- Model / Reference
- Accu-Plus EUDAMEDACC-FD63100/300RS EUDAMEDSKYMED EUDAMEDSK-FD-63100-300RS EUDAMEDSK-FD63100-300RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019814252 EUDAMED09551026270355 EUDAMED
- Basic UDI-DI
- 955101981MCRP-APNG EUDAMED955102627MCRP-SMMG EUDAMED
- Direct Marketing DI
- 09551019814252 EUDAMED09551026270355 EUDAMED
- EMDN Code
- Z12059009 ECG DATA MANAGEMENT SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Fukuda Denshi Op-114te by Isd Meditech Sdn. Bhd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 955101981MCRP-APNG | Class I | Active |
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Manufacturer
- Manufacturer
- Isd Meditech Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000043531
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 5109364d-dff8-455a-ba53-a243780e7149 61 fields · synced Oct 6, 2026
- EUDAMED 0cdff7a3-0a14-481d-859d-40eba06a3035 61 fields · synced May 17, 2026
- EUDAMED e4b4d32a-179a-44da-879a-c8363043dfaf 61 fields · synced Jul 14, 2026